GLP/GMP-certified, GCP compliant, EMA and FDA-inspected CRO specialized in bioanalysis and CMC STAND NR. 117

Kymos Group is an analytical CRO devoted to bioanalysis and CMC services for small molecules, biologics, and nucleic acids. We are GMP and GLP certified and we have been inspected by EMA and FDA. We work for the biotechnology, pharmaceutical, veterinary, fine chemistry, cosmetics, and nutraceutical industries.

We are located in Cerdanyola del Vallès (Barcelona, Spain) where we have two stand-alone buildings: one of 1,500 m2 for laboratories and a second one of 1,000 m2 for offices. Our labs are fully equipped with state-of-the-art technology.

The company has two subsidiaries: Pharmaprogress s.r.l. in Italy and Prolytic GMbH in Germany, as well as partnership agreements and collaborations with a wide range of local and multinational companies.

Our main areas of activity are:

BIOANALYSIS:

• Full bioequivalence studies for generics
• Bioanalysis of preclinical and clinical samples by mass spec (pK, PD, TK)
• Bioanalysis by ELISA and ECLA for biologics and biosimilars
• Biomarker analysis by MSD and Luminex
• Immunogenicity studies
• Cell-based assays
• Enzyme activity
• Nucleic acid bioanalysis by qPCR
• Full Preclinical studies

CMC:

• Analytical Method Development and Validation
• API analysis (compendial and non-compendial methods)
• Stability studies
• Characterization of biologics following the ICH Q6B
• Microbiology testing
• Batch Testing & Batch Release
• Elemental Impurities and N-Nitrosamine Impurities Analysis
• Extractables and Leachables